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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K233980
Device Name ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Meagan Robles
Correspondent
DePuy Synthes
Loughbeg
Ringaskiddy,  IE
Correspondent Contact Meagan Robles
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
HRY   JWH   KRR   MBH   NPJ  
OIY  
Date Received12/18/2023
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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